Are Patent Offices Ready for Personalized Medicine?

New science presents unique challenges to the patent system.

By R. Brian McCaslin

March 24, 2009 | Politicians, physicians, health insurers, and drug companies all see personalized medicine as a panacea that simultaneously will improve patient care, reduce health care and development costs, and ensure profitability. While the various constituencies have rallied around the potential of personalized medicine, various patent offices have not updated their procedures to accommodate the technologies driving personalized medicine.

Fundamental tenets of personalized medicine include the elucidation of an individual’s risk of developing a particular disease state and an assessment of the person’s likelihood of responding to a certain therapy. While the relevant assays can involve measuring a single, well-defined biomarker, they more likely comprise an evaluation of multiple biomarkers whose identities or function may not be known.

A suite of mass spectrometry platforms is typically used to identify and measure markers indicative of a disease state or susceptibility to therapy. Unfortunately for innovators striving to develop new proteomic assays, the current rules and procedures promulgated by patent offices were crafted in view of the old paradigm assays and have proven troublesome for the new technologies.

Prosecuting Proteomic Inventions

For example, current implementation of restriction and unity practice in, respectively, the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO), makes prosecuting the full scope of proteomic inventions prohibitive.

Consider the fictitious company BIORite, which employed tandem mass spectrometry and pattern recognition algorithms to identify 200 biomarkers for schizophrenia. BIORite is anxious to commercialize its technology and prepares a patent application with claims directed to a method of assessing schizophrenia in a patient by evaluating a clinical sample for the presence of at least one of biomarkers 1-200, which are identified by molecular weight.

More than likely, the USPTO and EPO will assert that such a claim encompasses 200 inventions which must be pursued in separate (i.e. 200) patent applications. Likewise, if BIORite decides to pursue foreign protection via the Patent Cooperation Treaty (PCT), the PCT examiner will likely consider the claims to encompass 200 inventions and require BIORite to pay $1,000 per additional invention (i.e. $199,000) to fully examine the application.

BIORite will also face an uphill battle to secure patent protection for each of the restricted inventions. Seeking to impose the perspective of the former paradigm on the new platform technologies, patent examiners are apt to reject the new claims on a variety of fronts.

For example, in the U.S., examiners may reject the claims (under 35 U.S.C. §112, ¶1) for allegedly lacking “written description.” European examiners could cite Article 84 for an alleged lack of clarity. In both instances, the rejections stem from a perceived obligation to completely identify the structural aspects of a protein marker before it can be used and claimed in an assay.

This misperception arises from a familiarity with assays of an earlier generation that employed single protein markers that were isolated and sequenced and whose biological functions had been elucidated.

Along similar lines, U.S. and European examiners may reject the assay claims for allegedly not being “enabled” (35 U.S.C. §112, ¶1 and Article 83, respectively). As with the above rejections, the examiner might argue that in the absence of complete structural and functional characteristics, the applicant has not enabled practitioners to make and use a biomarker.

Moreover, under current views of obviousness and inventiveness, U.S. and European examiners likely will argue that the new biomarkers are not patentable over the prior art. The examiners in this regard may argue that it would have been obvious to apply proteomic profiling technologies such as SELDI and pattern recognition algorithms to identify new makers for assessing the status of any disease or therapy because such tools have been used previously to identify biomarkers for various disease states.

The current approach to proteomic inventions employed by patent officials makes securing patent protection for the assays underpinning personalized medicine costly and difficult. To provide the requisite incentive for innovators to invest limited resources into developing the assays needed to make personalized medicine a reality, the offices should consider revamping their examination of proteomic inventions.

Adapting Key Markers

As meaningful change is unlikely in the near term, innovators seeking to patent proteomic-based assays should consider adapting their prosecution strategy to the current administrative landscape. In general, applicants should consider postponing the filing date of an application until more information about the biomarkers has been obtained. For example, rather than trying to secure coverage for every marker discovered, applicants should identify those key markers that generate the most compelling data. Likewise, the best marker combinations should be identified and claimed in a “Markush-type” claim. Finally, applicants should consider isolating and characterizing each biomarker of interest, and attempt to identify the structure and function of each of the claimed biomarkers.

R. Brian McCaslin, M.S., J.D. is an attorney at Foley & Lardner LLP. He can be reached at mccaslin@foley.com.

This article also appeared in the March-April 2009 issue of Bio-IT World Magazine.
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